OPIODUR 12 MICROGRAMS/HOUR TRANSDERMAL PATCH

Transcript

Package leaflet: Information for the patient

Opiodur

12 micrograms/hour transdermal patch
25 micrograms/hour transdermal patch
50 micrograms/hour transdermal patch
75 micrograms/hour transdermal patch
100 micrograms/hour transdermal patch
Fentanyl
• hese patches contain a strong painkiller.
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• nsure that old patches are removed before applying a new one.
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• atches must not be cut.
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• o not expose the patches to a heat source (such as a hot water bottle).
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• f you develop a fever tell your doctor immediately.
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• ollow the dosage instructions carefully and only change your patch every 72 hours.
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• f your breathing becomes shallow and weak take the patch off and seek medical help.
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Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
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Keep this leaflet. You may need to read it again.
- f you have any further questions, ask your doctor or pharmacist.
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- his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
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their signs of illness are the same as yours.
- f you get any side effects talk to your doctor, or pharmacist. This includes any possible side
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effects not listed in this leaflet.
What is in this leaflet
1. hat Opiodur is and what it is used for
4. ossible side effects
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2. hat you need to know before you use
5. ow to store Opiodur
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6. ontents of the pack and other
Opiodur
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3. ow to use Opiodur
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information
1.
What Opiodur is and what it is used for
Fentanyl is one of a group of strong painkillers called opioids.
The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
Adults
Opiodur is used for treatment of severe and long-lasting pain that can only adequately be managed
with strong pain relievers (opioids).
Children
Long term management of severe chronic pain in children receiving opioid therapy from 2 years
of age.
2.
What you need to know before you use Opiodur
Do not use Opiodur:
- f you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
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- f you suffer from pain which lasts only for a short period e.g. after a surgical procedure
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- f your central nervous system is severely impaired, for instance by brain injury.
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Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Opiodur.
WARNING:
Opiodur is a medical product that could be life-threatening to children. This is also the case with
used transdermal patches.
Bear in mind that the design of this medicinal product could be tempting to a child. Opiodur can
have life-threatening side effects in persons that are not using prescribed opioid medicines on
a regular basis.
Before starting to use Opiodur you should inform your doctor if you suffer from any of the below
disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a
lower dose of fentanyl.
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- sthma, respiratory depression or any lung disease
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- ow blood pressure or low blood volume
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- mpaired liver function
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- mpaired kidney function
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- f you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g.
headache, visual disturbances), changes in your state of consciousness or loss of consciousness
or coma
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- low irregular heartbeat (bradyarrhythmias)
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- yasthenia gravis (a disease causing tiredness and weakness of the muscles).
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• f you develop a fever while wearing Opiodur, tell your doctor as this may affect the way the
medicine passes through your skin.
• o not expose the patch to a direct heat source such as heating pads, hot water bottles,
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electric blankets, heat lamps, saunas and hot whirlpool spa baths. These may affect the way
the medicine works.

It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing
during hot summer days.
Tolerance, physical or psychological dependence may develop if you use Opiodur for a longer period.
Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or
illegal drugs.
If you are an elderly patient your doctor will monitor you more carefully, because it may be
necessary to prescribe a lower dose.
The patches should be not be cut into smaller parts, because the quality, efficacy and safety of such
divided patches have not been demonstrated.
The use of fentanyl patches may lead to a positive doping test. The use of fentanyl patches as a
doping agent may be hazardous to the health.
Children
Opiodur should not be administered to children under 2 years of age because there is limited
experience of use in children under that age. An exception can be made if the doctor has expressly
prescribed Opiodur.
Other medicines and Opiodur
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other
medicines.
In particular, tell your doctor or pharmacist if you are taking:
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- ther medicines for pain, such as other opioid painkillers (buprenorphine, nalbuphine or
pentazocine) medicines for helping you sleep
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- edicines to help you calm down (tranquillisers) and medicines for mental conditions
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- naesthetics, if you think you are going to have an anaesthetic, tell your doctor or dentist that
you are using Opiodur
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- edicines for relaxing your muscles
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- ome medicines used to treat depression (such as citalopram, duloxetine escitalopram,
fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)
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- ome medicines used to treat depression (MAOIs, e.g. moclobemide against depression or
selegiline against Parkinson’s disease). You should not use Opiodur within 14 days of stopping
these medicines.
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- efazodone, a medicine used to treat depression
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- imetidine, a medicine used to treat gastrointestinal diseases
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- edicines used for treating allergies or travel sickness (antihistamines/antiemetics). Especially
ones that make you sleepy.
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- ome antibiotics used to treat infection, such as erythromycin, clarithromycin or troleandomycin
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- ome antibiotics used to treat fungal infection, such as itraconazole, ketoconazole, fluconazole or
voriconazole
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- edicines used to treat HIV infection, such as ritonavir or nelfinavir
- edicines used to treat an irregular heart beat, such as amiodarone, diltiazem or verapamil
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Rifampicin (for treatment of TB)
- ome medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin)
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Your doctor will know which medicines are safe to take with Opiodur patches. You may need to be
closely monitored if you are taking some of the types of medicines listed above as this may increase
or prolong the therapeutic effects and side effects of Opiodur and thus may affect the strength of
Opiodur you need.
Opiodur with food, drink and alcohol
You should not consume alcohol during fentanyl treatment. Alcohol may increase the risk of
breathing problems. Simultaneous use of Opiodur and alcoholic beverages increases the risk of
severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound
sedation and coma.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
There are no adequate data from the use of Opiodur in pregnant women. If you are pregnant or
breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Opiodur should not be used during childbirth as the medication can affect the breathing of the
newborn child. Do not use Opiodur during pregnancy unless clearly necessary. Fentanyl is excreted
into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory
depression. Breastfeeding should therefore be discontinued during treatment and for at least
72 hours after removal of the patch.
Driving and using machines
Opiodur may impair mental and/or physical ability required for the performance of potentially
hazardous tasks such as driving a car or operating machinery. This has to be expected especially
at the beginning of treatment, at any change of dosage as well as in connection with alcohol or
tranquilizers. If you have been using the same dose of Opiodur for a longer period of time, your
doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or
operate dangerous machines while using Opiodur, unless your doctor has told you that such is
permitted.

3.
How to use Opiodur
Always use Opiodur exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will decide which strength of Opiodur is most suitable for you. Your doctor will base his
judgement on: the severity of your pain, your general condition and the type of pain treatment that
you have received so far.
According to your reaction the strength of the patch or the number of patches may need to be
adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects
fall gradually after the patch is removed. Do not discontinue treatment without consulting your
doctor.
Your first patch will start to work slowly, this may take as long as one day, so your doctor may give
you extra painkillers until your fentanyl transdermal patch starts working completely. After this,
Opiodur should help to relieve pain continuously and you should be able to stop taking these extra
painkillers. However sometimes you may still need extra painkillers.
Using and changing the patches
• here is enough medicine in each patch to last 3 days (72 hours)
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• ou should change your patch every third day, unless your doctor has told you otherwise.
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• lways remove the old patch before applying the new one.
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• lways change your patch at the same time of day every 3 days (72 hours)
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• ake a note of the day, date and time you apply a patch, to remind you when you need to
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change your patch.
• he following table shows you which day of the week to change your patch.
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Apply your patch on day

Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

→
→
→
→
→
→
→

Change your patch at the same time on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• pply the patch on a flat part of your upper body or arm.
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Children
• lways apply the patch to the upper back to make it difficult for your child to reach it or take it
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off.
• very so often check that the patch remains stuck to the skin.
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• t is important your child does not remove the patch and put it in their mouth as this could be
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life-threatening or even fatal.
• may take some time before the patch becomes fully effective. Therefore, your child might need
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additional painkillers until the patches become effective. Your doctor will advise you on this if it is
needed.
• hildren need to be monitored very closely for 48 hours after:
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- he first patch has been put on
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- higher dose patch has been put on.
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For you and your child, do not apply the patch on:
• he same place twice in a row
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• ensitive areas that you move a lot, cuts, spots or other skin blemishes.
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• kin that is very hairy, if there is a hair, do not shave it (shaving irritates the skin). Instead clip the
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hair as close to the skin as possible.
You should allow several days to pass before you put a new patch on the same area of skin.
Putting a patch on
Step 1: Preparing the skin
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Make sure your skin is completely clean, dry and cool before you put the patch on.
• f you need to clean the skin, just use cold water.
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• o not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the
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patch.
• o not stick a patch on straight after a hot bath or shower.
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Step 2: Open the pouch
• ach patch is sealed in its own pouch
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• ear or cut off the edge of the pouch completely (if you use scissors, cut close to the sealed edge
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of the pouch to avoid damaging the patch)
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Grasp both sides of the opened pouch and pull apart
• ake the patch out and use it straight away
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• eep the empty pouch to dispose of the used patch later
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• se each patch once only
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• o not take the patch out of its pouch until you are ready to use it
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• nspect the patch for any damage
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• o not use the patch if it has been divided, cut or looks damaged
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• ever divide or cut the patch
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Step 3: Peel and press
• ake sure that the patch will be covered by loose clothing and not stuck under a tight or
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elasticated band.
• arefully peel one half of the shiny plastic backing away from the centre of the patch. Try not to
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touch the sticky side of the patch.
• ress this sticky part of the patch onto the skin.
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• emove the other part of the backing and press the whole patch onto the skin with the palm of
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your hand.
• old for at least 30 seconds. Make sure it sticks well, especially the edges.
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Step 4: Disposing of the Patch
• s soon as you take the patch off, fold it firmly in half so that the sticky side sticks to itself.
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• ut it back in its original pouch and put the pouch in the bin with your household rubbish.
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• ven used patches contain some medicine which may harm children, so keep your used
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patches out of the sight and reach of children.
Step 5: Wash
Wash your hands afterwards with clean water.
More about using Opiodur patches
How quickly will the patches work?
• t may take up to a day before your first patch is working completely.
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• our doctor may give you extra painkillers for your first day or so.
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• fter this, the patch should help to relive pain continuously so that you can stop taking other
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painkillers. However, your doctor may still prescribe extra painkillers from time to time.
If your forget to change the patch
• f you forget, change your patch, as soon as you remember and make a note of the day and time.
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Change the patch again after 3 days (72 hours) as usual.
• f you are very late changing your patch, you should talk to your doctor because you might need
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extra painkillers, but do not apply an extra patch.
If you use too many patches or the wrong strength patch
• f you have stuck on too many patches or the wrong strength patch, take the patches off and
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contact a doctor or the nearest hospital straight away.
Signs of an overdose include trouble breathing or shallow breathing, tiredness, extreme
sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.
If the patch falls off
• f the patch falls off before it needs changing, stick a new one on straight away and make a note
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of the day and time. Use a new area on:
- our upper body or arm
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- our child’s upper back
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• eave another 3 days (72 hours) before changing the new patch as usual
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• f your patch keeps falling off, talk to your doctor, nurse or pharmacist.
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If a patch sticks to another person
• nly use the patch on the skin of the person who it is prescribed for.
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• ake sure the patch does not get rubbed off and sticks to your partner, especially in bed.
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• f a patch accidentally sticks to another person, take it off straight away and talk to your doctor.
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If your pain gets worse
• f your pain gets worse while you are using these patches, your doctor may try a higher strength
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patch, or give you extra painkillers (or both)
• f increasing the strength of the patch does not help, your doctor may stop the patches.
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If you want to stop using the patches
• alk to your doctor before you stop using these patches.
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• f you have been using them for some time your body may have got used to them. Stopping
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suddenly may make you feel unwell.
• f you stop using the patches, don’t start again without asking your doctor first. You might need a
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different strength patch when you restart.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, Opiodur can cause side effects, although not everybody gets them.
Take the patch off and tell your doctor or go to your nearest hospital straight away if you notice or
suspect any of the following. You may need urgent medical treatment.
• eeling unusually drowsy, breathing more slowly or weakly than expected. Very rarely these
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breathing difficulties can be life threatening or even fatal especially in people who have not used
strong opioid painkillers before. If you notice any of the above, follow the guidance above and
keep moving as much as possible.
• omplete block of the digestion channel (convulsive pain, vomiting, flatulence).
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Other side effects
Very common: may affect more than 1 in 10 people
Being sick (vomiting)
Dizziness
Somnolence
Headache.
Feeling sick (nausea)
Constipation
Common: may affect up to 1 in 10 people
Allergic reaction (hypersensitivity). An allergic reaction may include rash, itching, difficulty of
breathing or swelling of the face, lips, throat or tongue.
Awareness of unusual heart beats (also called palpitations), fast heart rate
High blood pressure
Lowered appetite
Sedation
Dry mouth
Nervousness
Difficulties in sleeping
Depression
Anxiety
Confusion
Hallucinations (seeing, feeling or hearing things that are not there)
Sensation of pins and needles
Shaking
Feeling giddy
Muscle spasms
Stomach pain
Breathing difficulties
Indigestion
Difficulty passing urine
Diarrhoea
Feeling cold
Excessive sweating
General feelings of discomfort
Tiredness, weakness
Swelling of hands, ankles or feet (water retention in the tissues)
Itchy skin, rashes or redness of the skin (Skin rash, skin reddening and itching will usually disappear
within one day after the patch has been removed).
Uncommon: may affect up to 1 in 100 people
Flu-like symptoms
Slow heart rate
Low blood pressure
Breathing more slowly or weakly
Decreased feeling of sensitivity, especially in the skin
Convulsions, fits or seizures
Bluish colouration of the skin
Feeling agitated, disorientated, excited or unusually carefree
Loss of memory
Eczema and/or other skin disorders including dermatitis where the patch is placed
Disorders of sexual function, erectile dysfunction
Complete obstruction of the intestine
Muscle twitching
Feeling of body temperature changes
Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)
Rare: may affect up to 1 in 1,000 people
Tiny pupils
Hazy vision
Dilated blood vessels
Apnoea
Insufficient oxygen and increased carbon dioxide in the blood (respiratory acidosis)
Incomplete obstruction of the small or large intestine
Hiccups
Dermatitis at the application site
Eczema at the application site.
Very rare: may affect up to 1 in 10,000 people
Loss of muscle coordination
Painful gases in the stomach or the guts
Unusual low production of urine
Pain in the urine bladder
Not known: frequency cannot be estimated from the available data
Generalised acute allergic reactions which can be life-threatening (anaphylactic shock)
Abnormally slow breathing rate
Spitting of blood
Unusual accumulation of blood in lungs
Inflammation in the throat.
Like with other strong painkillers, repeated use of the patches may make you become tolerant to the
medicine or become physical and/or psychological dependent on it.

Withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering are possible if you
switch from a different painkiller to Opiodur or if you stop your therapy suddenly.
There have been very rare reports of newborn infants experiencing withdrawal effects after their
mothers have used Opiodur for a long time during pregnancy.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Opiodur
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Store in the original sachet in order to protect from moisture.
Disposal information
High quantities of fentanyl remain in the patches even after use. Any unused medicinal product and
any used transdermal patches, folded with the adhesive surfaces inwards, should be discarded or
returned to the pharmacy.
These measures will help to protect the environment. Do not throw away any medicines via
wastewater or household waste.
Contents of the pack and other information
6.
What Opiodur contains
• he active substance is: fentanyl.
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Each Opiodur 12 micrograms/hour transdermal patch contains 1.375 mg of fentanyl in a patch
size of 5 cm², releasing 12 micrograms of fentanyl per hour.
Each Opiodur 25 micrograms/hour transdermal patch contains 2.75 mg of fentanyl in a patch
size of 10 cm², releasing 25 micrograms of fentanyl per hour.
Each Opiodur 50 micrograms/hour transdermal patch contains 5.5 mg of fentanyl in a patch size
of 20 cm², releasing 50 micrograms of fentanyl per hour.
Each Opiodur 75 micrograms/hour transdermal patch contains 8.25 mg of fentanyl in a patch
size of 30 cm², releasing 75 micrograms of fentanyl per hour.
Each Opiodur 100 micrograms/hour transdermal patch contains 11.0 mg of fentanyl in a patch
size of 40 cm², releasing 100 micrograms of fentanyl per hour.
• he other ingredients are:
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Skin adhesive Layer
Overlay liner
Silicone adhesive (polydimethylsiloxane,
Polyethylene terephthalate film with
silicate resin)
fluorocarbon release coating.
Polydimethylsiloxane
Backing Layer
Protective liner
Pigmented polyethylene terephthalate/
Polyethylene terephthalate film with
ethylene vinyl acetate copolymer film
fluorocarbon release coating
Drug adhesive Layer
Printing ink
Silicone adhesive (polydimethylsiloxane,
Red ink
silicate resin) Polydimethylsiloxane
Rate controlling membrane
Ethylene vinyl acetate copolymer film
What Opiodur looks like and contents of the pack
Opiodur transdermal patch is a rectangular, tan coloured patch which is placed between two clear
protective layers which need to be removed prior to application. The patches are imprinted in red
ink with:
Fentanyl 12 µg/h
Fentanyl 50 µg/h
Fentanyl 100 µg/h
Fentanyl 25 µg/h
Fentanyl 75 µg/h
Opiodur is available in packs of 3, 4, 5, 8, 9, 10, 16, 19 or 20 transdermal patches.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
Pfizer Limited,
Lavipharm S.A.,
Ramsgate Road,
Agias Marinas str,
Sandwich,
19002 Peania,
Kent CT13 9NJ,
Athens,
United Kingdom.
Greece.
This leaflet was last revised in 10/2013.
Ref: gxFE 2_0 UK

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